WG 7 - TC 66/WG 7

IEC 61010-2-040:2015 specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields, when used under the environmental conditions of 1.4. It has the status of a group safety publication, as specified in IEC Guide 104. This second edition cancels and replaces the first edition published in 2005. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) A new clause (4.3.2.101) has been added for non-electrical supplies and services.
b) Additional requirements for marking and documentation (Clause 5) have been added.
c) Additional requirements for protection against mechanical hazards (Clause 7) have been included.
d) Additional requirements for protection against radiation, including laser sources, and against sonic and ultrasonic pressure (Clause 12) have been included.

This International Standard specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields, when used under the environmental conditions of 1.4. This document consolidates the requirements of four standards, IEC 61010-2-041, IEC 61010-2-042, IEC 61010-2-043 and IEC 61010-2-045, which are withdrawn, and aligns them with the second edition (2001) of IEC 61010-1:Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements. It has the status of a group safety publication in accordance with IEC Guide 104.

Applies to washer disinfectors and other equipment used for washing and disinfection. This is for the treatment of soiled items used in the medical, veterinary, pharmaceutical and laboratory fields. For domestic dishwashers see IEC 60335-2-5, for commercial dishwashers see IEC 60335-2-58.

Applies to autoclaves and sterilizers, including those with an automatic loading and unloading system, which incorporate a chamber using toxic gas intended for the treatment of medical materials, and for laboratory processes, for example for sterilization. This standard has the status of a group safety publication.

Applies to sterilizers, including those having an automatic loading and unloading system, with one ore more chambers operating at approximately atmospheric pressure and using hot air or hot inertgas intended for the treatment of medical materials, and for laboratory processes. This standard has the status of a group safety publication.